A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia

AbbVie

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: ABT-263

Study type: Interventional

Funder types: Industry

Identifiers

NCT00481091

2007-002143-25 (EudraCT Number)

M06-873

Details and patient eligibility

About

The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 under two different dosing schedules with the objective of defining the dose limiting toxicity and maximum tolerated dose. The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy. The Extension Study portion will allow active subjects to continue to receive ABT-263 for up to 11 years after the last subject transitions with less frequent study evaluations.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Relapsed or refractory CLL and require treatment in opinion of investigator.
• Eastern Cooperative Oncology Group (ECOG) <= 1.
• Adequate bone marrow independent of growth factor support, renal and hepatic function per defined laboratory criteria.

Exclusion criteria

• History or is clinically suspicious for cancer-related Central Nervous System disease.
• Receipt of allogenic or autologous stem cell transplant.
• Recent history (within 1 year of first dose) of underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.
• Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
• Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions (within 1 year of first dose).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

60 participants in 10 patient groups

Navitoclax 14/21 Day Cycle: 10 mg

Experimental group

Description:

Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.

Treatment:

Drug: ABT-263

Navitoclax 14/21 Day Cycle: 110 mg

Experimental group

Description:

Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.

Treatment:

Drug: ABT-263

Navitoclax 14/21 Day Cycle: 200 mg

Experimental group

Description:

Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.

Treatment:

Drug: ABT-263

Navitoclax 14/21 Day Cycle: 250 mg

Experimental group

Description:

Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.

Treatment:

Drug: ABT-263

Navitoclax 21/21 Day Cycle: 125 mg

Experimental group

Description:

Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.

Treatment:

Drug: ABT-263

Navitoclax 21/21 Day Cycle: 200 mg

Experimental group

Description:

Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.

Treatment:

Drug: ABT-263

Navitoclax 21/21 Day Cycle: 250 mg

Experimental group

Description:

Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.

Treatment:

Drug: ABT-263

Navitoclax 21/21 Day Cycle: 300 mg

Experimental group

Description:

Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.

Treatment:

Drug: ABT-263

Phase 2: Navitoclax 100 mg

Experimental group

Description:

Navitoclax 100 mg in participants with CLL who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).

Treatment:

Drug: ABT-263

Phase 2: Navitoclax 250 mg

Experimental group

Description:

Navitoclax 250 mg in participants with CLL who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).

Treatment:

Drug: ABT-263